A Drug Company Finds Itself With a Headache and Over Its Head with Unlawful Promotional Messaging

In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And FDA’s Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third letter in 2021 – its first Untitled Letter this year — for unlawful promotion.¹  In this case, OPDP took exception to a direct-to-consumer video of an interview with Khloe Kardashian, a paid spokesperson for a pharmaceutical company that marketed a prescription drug product for acute treatment of migraine with or without aura in adults. The video originally appeared on the television show, The View, and can be accessed on its YouTube page. The drug company was identified as a sponsor of the television program. The video also included a web address to direct the viewer to the sponsor’s website.

A number of years ago, OPDP issued a Warning Letter to another company when one of Ms. Kardashian’s sisters, a paid spokesperson for the drug company and product, posted a message to her Instagram account that ran afoul of FDA’s promotional requirements.

Part of the title of this Bulletin, “Over Its Head,” is a play on the mid-1970’s song, “Over My Head,” by Fleetwood Mac, and brings up the challenges of product promotion in live, often unrehearsed settings.

This Bulletin highlights some of OPDP’s concerns described in the Untitled Letter.

• OPDP said that the spokesperson overstated efficacy when she claimed that the product could work in approximately 15-30 minutes. The clinical studies from the Prescribing Information (PI) did not include any pre-specified endpoints that evaluated the efficacy of the drug at 15 or 30 minutes after dosing. Instead, the coprimary endpoints (freedom from pain and most bothersome symptoms) were measured beginning at 2 hours after dosing with the product and placebo. Based on the studies, a claim that could be supported by the PI might be that relief should start in 2 hours (not 15 or 30 minutes). OPDP acknowledged that this might have been the spokesperson’s personal experience with the drug, and the video included a super that, “AS EVERYONE EXPERIENCES MIGRAINES DIFFERENTLY, TREATMENT RESULTS MAY VARY.” However, this disclaimer and Ms. Kardashian’s personal experience did not “mitigate the misleading impression” that the product could provide relief within 15-30 minutes when the PI and data said otherwise.

• The spokesperson also suggested that the product was a “gamechanger” and other products she took didn’t work. OPDP said that there was no evidence to suggest the product was clinically superior to, more effective than, or a “gamechanger” compared to other prescriptions and over-the-counter products (i.e., they were unsupported comparative claims). Therefore, the statements were misleading.

• Kardashian did not include the full indication when she spoke; the indication also included a Limitation of Use. The product’s full indication was that it is approved for acute treatment of migraine, and the Limitation of Use is that it is not indicated for the preventive treatment of migraine. The full indication is provided “briefly, at the end of the video, after the interview portion, in a script/text format on the screen,” but OPDP said it “did not mitigate the misleading impression.” We find it amusing how OPDP described the presentation – “briefly,” “at the end,” “after,” and “in a script/text format on the screen,” almost counting the ways, individually, that the presentation failed.

• The video did not provide risk information with the same prominence as the benefit information. The spokesperson provided the positive information in the audio and video, but the risk information was only presented in text format and in small format. OPDP noted that the risk information appeared only for four seconds at the end of the video, after Ms. Kardashian’s talk. The video did not inform the viewer that important risk information would follow the presentation when the spokesperson was done, but the television host said, “we’ll be right back,” which suggested the segment was over.

• The company failed to submit a Form FDA-2253, which is required at the time of initial dissemination of labeling and at the time of initial publication of an advertisement for a prescription drug product.

AGG Observations

• We see many familiar themes as those OPDP raised in the two Warning Letters issued in 2021 and some of the letters in 2020: minimization or lack of prominence for risk information, not including full indication/not including limitations of use, overstatement of efficacy, and not submitting a Form 2253.

• A Bad Ad complaint prompted the Untitled Letter.

• Comparative claims must be supported by data, typically head-to-head studies.

• Personal experience of a spokesperson, while may be true for that individual, must be typical and consistent with what FDA has reviewed and approved in the PI. A qualifier and disclaimer are not sufficient to mitigate a potential false or misleading message.

• It is important that paid spokespeople, whether celebrities, patients, or doctors, are properly trained on FDA labeling and promotional requirements. Prepared speeches, presentations, and commercials leave less room for error. However, real-time-interviews, active social media blogs, and interactive discussions are more prone to off-the-cuff mistakes and failure to follow the regulatory script. While it might be awkward for an individual to raise adverse event information during an interview, and companies are hesitant to script others’ talks, spokespeople are company agents. In addition, while adding supers after the fact may minimize the enforcement risk, but, as we see, they do not eliminate the risk.

• Companies should not perpetuate potential regulatory problems by posting problematic live presentations on company-controlled forums without ensuring they are compliant.  And, perhaps, after a thorough review, the presentation itself might not be used at all if it cannot be shown in an FDA-compliant manner (and, particularly, if it is not submitted on Form FDA-2253).

[1] The letter can be accessed at www.fda.gov/medical/146528/download.